BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1992685 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-01028
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) DEVICE DID NOT MEET EXPECTED LONGEVITY. DISCLAIMER: SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. THE LV AMPLITUDE WAS DECREASED "WITH GOOD RESULTS." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE LEFT VENTRICULAR LEAD AND DEVICE WERE EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED TO MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. THE LV AMPLITUDE WAS DECREASED "WITH GOOD RESULTS." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THE LEFT VENTRICULAR LEAD AND DEVICE WERE EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED TO MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. LATER REPORTED THE LEFT VENTRICULAR LEAD WAS EXPLANTED DUE TO "NON FUNCTIONAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD